National Institute of Biomedical Imaging and
Bioengineering (NIBIB)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
National Institute of Nursing Research (NINR)
Office of Behavioral and Social Sciences Research (OBSSR)

This FOA encourages Research Project Grant (R01)
applications for research and development of technologies that monitor health
or deliver care in a real-time, accessible, effective, and minimally
obtrusive way. These systems are expected to integrate, process, analyze,
communicate, and present data so that the individuals are engaged and
empowered in their own healthcare with reduced burden to care providers. The
development of these technology systems has the potential to significantly
improve the quality of life for people with disabilities, people aging with
mild impairments, as well as individuals with chronic conditions.

Key Dates

Posted Date

February 26, 2014

Open Date (Earliest Submission Date)

August 23, 2014

Letter of Intent Due Date(s)

30 days before the application due date

Application Due Date(s)

September 23, 2014; September 23, 2015; September 23, 2016,
by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

January 7, 2015; January 7, 2016; January 7, 2017 by 5:00
PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

Scientific Merit Review

February-March 2015, February-March 2016, February-March
2017

Advisory Council Review

May 2015, May 2016, May 2017

Earliest Start Date

July 2015, July 2016, July 2017

Expiration Date

January 8, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

There are several options to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons. Learn more.

The average age of Americans is increasing and chronic
conditions are becoming more prevalent. There is a need to improve the
effectiveness of disease prevention, to improve access to healthcare, and to
sustain healthy independent living. At the same time, there is an increased
availability of new technologies and an ever-improving health information
technology infrastructure. Advances in bioengineering coupled with the
aforementioned needs of society suggest a ripe opportunity for the design and
development of home or mobile technologies that enable functional independence
and can improve quality of life for people with disabilities, chronic
conditions, or mild impairments associated with aging. Home-health and
mobile-health technologies are expected to function not only as monitoring
devices, but as essential components in the delivery of healthcare.

This FOA encourages Research Project Grant (R01)
applications for research, development, and evaluation of systems that monitor
health, inform clinical decisions, or deliver therapies in a real-time and
minimally obtrusive way. These are technologies that enable monitoring of
personal motion, vital signs, and physiological measures in a manner that
minimizes disruption to an individual’s daily routine and at all times protects
their privacy, dignity, and comfort. These systems are expected to integrate,
process, analyze, communicate, and present data so that the individuals are
engaged and empowered in their own healthcare with reduced burden to care
providers. Effective application of home-based and mobile technologies has the
potential to increase adherence to rehabilitation and medical regimens, reduce
incidence of avoidable post-acute complications, and improve self-care
management of chronic conditions. Exploratory projects to develop novel
components of such systems are referred to the companion FOA for R21 grants [Design and
Development of Novel Technologies for Healthy Independent Living (R21)].

Health care and medicine rely on effective detection and
characterization of a person's physical and mental states and of significant
changes to those states. Current methods to assess these indicators of
well-being are performed at the convenience of the care provider and usually
assume that observations during an office visit represent typical function.
Furthermore, these methods may involve contrived or burdensome tests or depend
heavily on recall. Thus, current methods may miss significant acute events or
important signals of declining function or may poorly characterize detected
events.

Technologies designed for home and mobile monitoring are
intended to overcome these limitations. They have the potential to capture
rare, irregular, or transient events; symptoms that are difficult for a patient
to report; and changes in condition that evolve slowly over time. These
improvements, in turn, could yield more accurate and earlier detection of
changes that may interfere with healthy and independent living.

Specific Areas of Research Interest

Projects that address a specific and well-characterized
clinical need will be considered of high potential impact. In designing
technology solutions, applicants are advised to consider the context in which
their technology will be used and the needs of the expected users. In many
cases this will mean involving the end-users -- whether people with
disabilities, elderly people with mild impairments, or people with chronic
medical conditions -- in the research and development process. It is expected
that many of these projects will be collaborations between engineers and
computer scientists; and nurses, physical therapists, doctors, and other
clinicians. Behavioral scientists may also be involved in identifying the best
approaches to ensure adoption of the approach and patient engagement and motivation.
Projects should include the appropriate outcome measures, particularly those
that are clinically meaningful to the patient population of interest.

The technologies developed with funding through this FOA are
expected to be integrated systems or, if they are novel components, be easily
integrated into existing systems. Proposed devices should interoperate with
other home-based or mobile technologies and communicate with existing health
information technology systems, as appropriate. Some other technical features
that are expected to lead to successful systems are: reliability, robustness
(i.e. ability to function in a variety of operating environments), safety,
simplicity, reliance on the appropriate baseline information, contextual
awareness, inclusion of software to support decision-making, and consideration
of power consumption. Furthermore, systems will ideally integrate information
from multiple sensors, appropriate clinical information, and ambient data such
as temperature or global position. Proposed systems should incorporate existing
standards and consider the regulatory environment where appropriate.

Furthermore, successful systems that are likely to achieve
wide-spread dissemination must consider human factors. That is, they should: be
reliable, robust, safe, and simple (four traits also found as technical
features); be aesthetically acceptable and unobtrusive; uphold the patient’s
privacy preferences; be easy to use and have intuitive user interfaces with
consideration for user disability or impairment; provide feedback in meaningful
forms, whether auditory, visual, or tactile; maintain or promote social
engagement; and address a heterogeneous population where one size does not fit
all. Perhaps most importantly, a system for healthy independent living
should engage, empower, and motivate the individual with respect to his/her own
healthcare.

The objective of any home-based or mobile monitoring system
that includes an alarm or alert feature is that it be sensitive (avoid
false-negatives) and specific (avoid false-positives) as appropriate to the
situation and how the system is used. Ideally, the alerts or cueing of the
system will be customized to the needs and preferences of the user.

Some examples of appropriate topics for this FOA include but
are not limited to:

Therapeutic or management systems to address physical or
cognitive decline

Fall detection or prevention systems

Systems to monitor and facilitate sleep health

Technologies aimed at helping the lay care-giver or professional
provider

Systems that monitor health, inform clinical decisions, or
deliver therapies in a real-time and minimally obtrusive way

Technologies that enable monitoring of personal motion, vital
signs, and physiological measures, including those for cardiovascular disease
(e.g., devices or sensors to detect acute myocardial infarction or heart
failure), in a manner that minimizes disruption to an individual’s daily
routine and at all times protects their privacy, dignity and comfort

Applicants may also consider consulting the above programs
or other publicly-available resources to benefit from prior efforts to identify
and characterize clinical and health-related needs. The available information
may provide valuable input into the development of technical solutions. For
example, AHRQ's EPC program and DEcIDE Network release evidence reports,
research gap report, and technical briefs that summarize published findings on
health care delivery issues. These can be found via the Effective Health Care Program site.

Applications submitted for this funding opportunity are
expected to propose the development of integrated systems or components that
can be easily integrated into existing systems. Applicants will be advised to
consider carefully the context in which their technology will be used, the
needs of the expected users, interoperability with other home-based
technologies, and interaction with existing health information technology
systems.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission

The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited but need to reflect the
actual needs of the proposed project.

Award Project Period

5 years

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants must
have an active DUNS number and SAM registration in order to complete the eRA
Commons registration. Organizations can register with the eRA Commons as they
are working through their SAM or Grants.gov registration. eRA Commons requires
organizations to identify at least one Signing Official (SO) and at least one
Program Director/Principal Investigator (PD/PI) account in order to submit an
application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing Official,
they must have two distinct eRA Commons accounts, one for each role. Obtaining
an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all
applicable components, required and optional. Please note that some components
marked optional in the application package are required for submission of
applications for this FOA. Follow all instructions in the SF424 (R&R)
Application Guide to ensure you complete all appropriate “optional” components.

Instructions for Application Submission

The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must
be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide
must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Appendix:
Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions
for completing Planned Enrollment Reports as described in the SF424 (R&R)
Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions
for completing Cumulative Inclusion Enrollment Report
as described in the SF424 (R&R) Application Guide.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies
described in the NIH Grants
Policy Statement, and procedures for foreign institutions described
throughout the SF424 (R&R) Application Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the application
due date. If a Changed/Corrected application is submitted after the deadline,
the application will be considered late.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) must include their eRA Commons ID in the
Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management. Additional information may be
found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Applications that are
incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field? Does the application make a compelling
case for the need for the development of this technology? Are human factors
such as the abilities, comfort, dignity, and privacy of care-givers and
care-receivers appropriately addressed? What is the likelihood that this
technology will ultimately see widespread adoption?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD/PI, do the investigators have
complementary and integrated expertise; are their leadership approach, governance
and organizational structure appropriate for the project? Are persons with
disabilities/diseases/conditions and/or experts familiar with their
circumstances members of the investigative team?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?

If the project involves human subjects and/or NIH-defined clinical research,
are the plans to address 1) the protection of human subjects from research
risks, and 2) inclusion (or exclusion) of individuals on the basis of
sex/gender, race, and ethnicity, as well as the inclusion or exclusion of
children, justified in terms of the scientific goals and research strategy
proposed? Is the approach sensitive to the existing technical and social
context into which the proposed system will be introduced? Has
interoperability been appropriately addressed and existing standards
incorporated where relevant? Is the design approach one that considers a whole
system of health maintenance and care delivery? Are persons with
disabilities/disease/conditions appropriately involved in the design process?
Are efficacy, safety, accessibility and usability by persons with
disabilities/disease/conditions addressed where appropriate? Was the
approach to determining the need for the proposed technology suitable?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Guidelines
for the Review of Human Subjects.

Inclusion of Women, Minorities, and
Children

When the proposed project involves human subjects
and/or NIH-defined clinical research, the committee will evaluate the proposed
plans for the inclusion (or exclusion) of individuals on the basis of sex/gender,
race, and ethnicity, as well as the inclusion (or exclusion) of children to
determine if it is justified in terms of the scientific goals and research
strategy proposed. For additional information on review of the Inclusion
section, please refer to the Guidelines
for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

For Renewals, the committee will consider the
progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the CSR, in
accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications. Following
initial peer review, recommended applications will receive a second level of
review by the appropriate national Advisory Council or Board. The following
will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

When multiple years are involved, awardees will be required
to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR)
and financial statements as required in the NIH Grants
Policy Statement.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.